Website Offers Guidance on Breast Density Notification Laws

December 01, 2013

A group of breast imagers have developed a website to navigate challenges posed by breast density notification laws.

Nine months before the California breast density reporting law took effect in April 2013, a group of breast imagers and breast cancer risk specialists were already preparing for the enormous impact the legislation could have on America’s most populous state.

The California law mandates written notification to women, after screening mammography, of their tissue density and the need to discuss screening options with their primary care physicians. Because nearly 50 percent of women who undergo screening mammography are classified as having either heterogeneously or extremely dense breast tissue, as many as two million notification letters could go out in California alone, with a resultant significant increase in supplementary screening by MR imaging and ultrasound.

“Patients who receive one of these notification letters generally ask, ‘What do I do now?’ and ‘Does this mean that I am likely to get breast cancer?” according to Jafi A. Lipson, M.D., assistant professor of radiology at Stanford University School of Medicine. “The upshot is that a woman will read the letter and look to her primary care doctor for guidelines that the law does not provide. Radiologists might not be on the front lines, but they also need to be ready to answer questions with evidence-based information that offers clear guidance.”

Soon after the law was passed, Debra Ikeda, M.D., chief of breast imaging and professor of radiology at Stanford University School of Medicine, and colleagues formed the California Breast Density Information Group (CBDIG) to develop a common response framework to help referring physicians, patients and radiologists navigate the new challenges posed by the law. The result of their efforts is a user-friendly, evidence-based website (breastdensity.info) that contains information about breast density, breast cancer risk assessment and supplementary imaging, along with educational tools for patients and physicians. For example, physicians can access flow charts illustrating clinical scenarios that they may encounter while complying with the law in California. (See sidebar.)

A special report on the CBDIG findings published online September 10, 2013, in Radiology (before print) was authored by Elissa R. Price, M.D., assistant professor of clinical radiology of the Department of Radiology and Biomedical Imaging at the University of California, San Francisco, and her colleagues.

Legislation Should “Trigger a Discussion”

Regardless of the debate, “the laws are a reality,” said Dr. Lipson, spokesperson for CBDIG. “That was the focus of CBDIG when developing these resources—not discussing whether the laws are right or wrong.”

Dr. Lipson and colleagues researched scientific evidence to develop a response to the key elements of the law. Overall, CBDIG recommends an individualized risk-based approach for guiding decision-making. Women with a high risk of breast cancer, such as those with BRCA genetic mutations, are more likely to benefit from additional screening with MR imaging, ultrasound or tomosynthesis. For women with intermediate risk, the decision to have screening MR imaging should be made on a case-by-case basis using a shared decision-making approach, Dr. Lipson said.

The benefits of additional screening are diminished in women who are not at high risk for breast cancer, while the potential harms remain the same, Dr. Lipson said.

(Click to enlarge) Created by the California Breast Density Information Group (CBDIG), the user-friendly, evidence-based website (www.breastdensity.info) contains information about breast density, breast cancer risk assessment and supplementary imaging along with educational tools for patients and physicians.

She stressed that supplemental screening recommendations should be based in the context of other breast cancer risks, rather than just density, and that the notification letter should “trigger a discussion between women and their doctors about the overall breast cancer risk,” as the law intended.

Radiologists, according to Dr. Price and colleagues, should also be part of the conversation. “In our era of patient-centered care and personalized medicine, breast density notification legislation provides an opportunity for radiologists to engage with referring clinicians and patients,” Dr. Price noted.

Legislation Presents Drawbacks

Since the first breast density notification law was passed in Connecticut in 2009, the movement for more widespread legislation has gained considerable momentum based largely on a grassroots effort by organizations including Are You Dense, Inc., and Are You Dense Advocacy, Inc., led by executive director and founder, Nancy M. Cappello, Ph.D., who received an advanced breast cancer diagnosis in 2004 within weeks of a normal mammogram. “I was told my extremely dense breast tissue prevented my years of mammograms from detecting my cancer at an earlier stage,” Dr. Cappello said.

As of October 2013, 12 states have passed similar legislation, while 10 others are considering breast density notification laws. A federal breast density notification law is pending, and the U.S. Food and Drug Administration (FDA) is also considering modifications to national mammography reporting guidelines to include breast density notification.

While mammography is still considered the best modality for population-based breast cancer screening, its sensitivity decreases by up to 20 percent in women with dense breast tissue and up to 50 percent in women at high lifetime risk of breast cancer who also have extremely dense breasts, research shows.

Dr. Cappello stresses that breast density laws are critical to realizing the ultimate goal “of women being notified of their breast tissue composition to inform their conversations with healthcare providers about their personal screening surveillance,” and says no roadblock will stop her from getting this critical health information out to women.

Nevertheless, some physicians point to potential drawbacks to breast density laws, including patients’ confusion about screening follow-ups, an increase in false-positives, and reimbursement issues. In addition, the broad classification of breast density does not take into account the varying levels of risk among patients with different breast densities, Dr. Lipson said.

Although the American College of Radiology (ACR) supports including information about breast density in the mammography report sent to physicians, the organization is cautious about supporting mandatory notification to patients. “While the ACR is not opposed to including parenchymal breast information in the lay summary, we urge strong consideration of the benefits, possible harms and unintended consequences of doing so,” the ACR position statement on breast density states.

While she supports the breast density notification law in effect in Virginia since 2012, Jennifer A. Harvey, M.D., head of the Division of Breast Imaging and a professor of radiology at the University of Virginia Hospital Health System, Charlottesville, stresses that education for all those affected is critical.

“I’ve had more questions from healthcare providers about supplementary screening than I have from patients,” said Dr. Harvey, a presenter of the RSNA 2013 Special Interest Session: Breast Density: Risk Assessment, Communication, and Approaches to Supplemental Imaging. “But I believe patients have a right to this information. I think it gets to the issue of trust between a patient and physician regarding decision making.”

Web Extras

Access the California Breast Density Information Group (CBDIG) website at www.breastdensity.info. The site features a PDF of guidelines for healthcare providers and an ACR patient brochure that can be printed out and distributed.